“…Nevertheless, the list is agreed upon by consensus among software developers and research, offering a perfect starting point for a mixed method approach to the development of software as medical device. (Münch, 2016) Continuous improvement through iterative steps to establish a smoother flow (Hibbs, Jewett, & Sullivan, 2009) Create only necessary documentation (Graziotin & Jedlitschka, 2013;Shalloway, 2018) Establish software documentation planning to deliver necessary documentation to notified bodies (Stellman & Greene, 2014) Establish group performance, no heroic individuals (Shalloway, 2018) Implementation of Kanban approach within quality system (Münch, 2016;Shalloway, 2018) Implementation of virtual Kanban board (Münch, 2016) Link voice of customers to user and usability requirements (Cawley et al, 2012;Raffo, Mehta, Anderson, & Harmon, 2010) Manage pair programming (Al-Baik & Miller, 2015;Mc Hugh et al, 2017) Optimise the whole process and provide feedback (Cawley et al, 2012;Poppendieck & Poppendieck, 2007) PDCA (plan do check act) cycle (Deming, 1986) Radical improvement within a limited time (Lester, 2008;Wang et al, 2012) Visualise the workflow (Poppendieck & Poppendieck, 2007) Mixed method Kanban SDLC American and European guidelines clearly outline the tailoring of a software development lifecycle in order to standardize development practices and to achieve maximum impact (Zeegers, 2018). This paper focuses on the implementation of Kanban practices within a plan-driven medical device software development lifecycle.…”